Instant Hand Sanitizer (gel-type)
NDC Package 53341-056-27

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Instant Hand Sanitizer (gel-type) is for hand cleaning to decrease bacteria on skin that could cause disease.Do not use in the eyes. Marketed by Tranzonic Companies, this product is identified by NDC 53341-056 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
53341-056-27
Package Description
800 mL in 1 BAG
Product Code
53341-056
11-Digit Billing Format
53341005627

Clinical Specifications

Proprietary Name
Instant Hand Sanitizer (gel-type)
Dosage Form
-
Usage Information
For hand cleaning to decrease bacteria on skin that could cause disease.Do not use in the eyes. In case of contact, immediately flush with water.Stop use and ask a doctor if irritation or rash appears and lasts.Keep out of reach of children. If swallowed, contact a physician or poison center.

Regulatory & Marketing

Labeler Name
Tranzonic Companies
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
11-05-2013
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53341-056-27 identifies a specific commercial package of 800 ml in 1 bag of Instant Hand Sanitizer (gel-type), labeled by Tranzonic Companies. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Tranzonic Companies on November 05, 2013. The current certification is valid through December 31, 2017.

How is this Tranzonic Companies product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53341005627. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53341-056-27
11-Digit CMS (5-4-2)
53341-0056-27

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.